Transition matching stent

ABSTRACT

The bending flexibility profile of a stent closely matches the flexibilities of the stent delivery system on either side of the stent. In one embodiment, a stent has a longitudinal axis and at least one link attaching each ring to an adjacent ring. The links closest to the stent end rings have the greatest bending flexibility and the links closest to the center of the stent have the least bending flexibility.

BACKGROUND OF THE INVENTION

The invention relates to vascular repair devices, and in particularintravascular stents, which are adapted to be implanted into a patient'sbody lumen, such as a blood vessel or coronary artery, to maintain thepatency thereof. Stents are particularly useful in the treatment ofatherosclerotic stenosis in arteries and blood vessels.

Stents are generally tubular shaped devices which function to hold opena segment of the blood vessel or other body lumens such as a coronaryartery. They also are suitable for use to support and hold back adissected arterial lining that can occlude the fluid passageway. Atpresent, there are numerous commercial stents being marketed throughoutthe world. For example, the prior art stents depicted in FIGS. 1-4 havemultiple cylindrical rings connected by one or more undulating links.

FIG. 1 depicts a prior art stent 10 mounted on a conventional catheterassembly 12 which is used to deliver the stent and implant it in a bodylumen, such as a coronary artery, peripheral artery, or other vessel orlumen within the body. The catheter assembly includes a catheter shaft13 which has a proximal end 14 and a distal end 16. The catheterassembly is configured to advance through the patient's vascular systemby advancing over a guidewire by any of the well known methods of anover-the-wire system (not shown) or a well known rapid exchange cathetersystem, such as the one shown in FIG. 1.

Catheter assembly 12 as depicted in FIG. 1 is of the well known rapidexchange type which includes an RX port 20 where the guidewire 18 willexecute the catheter. The distal end of the guidewire 18 exits thecatheter distal end 16 so that the catheter advances along the guidewireon a section of the catheter between the RX port 20 and the catheterdistal 16. As is known in the art, the guidewire lumen which receivesthe guidewire is sized for receiving various diameter guidewires to suita particular application. The stent is mounted on the expandable member22 (balloon) and is crimped tightly thereon so that the stent andexpandable member present a low profile diameter for delivery throughthe arteries.

As shown in FIG. 1, a partial cross-section of an artery 24 is shownwith a small amount of plaque that has been previously treated by anangioplasty or other repair procedure. Stent 10 is used to repair adiseased or damaged arterial wall which may include the plaque 26 asshown in FIG. 1, or a dissection, or a flap which are sometimes found inthe coronary arteries, peripheral arteries and other vessels.

In a typical procedure to implant prior art stent 10, the guidewire 18is advanced through the patient's vascular system by well known methodsso that the distal end of the guidewire is advanced past the plaque ordiseased area 26. Prior to implanting the stent, the cardiologist maywish to perform an angioplasty procedure or other procedure (i.e.,atherectomy) in order to open the vessel and remodel the diseased area.Thereafter, the stent delivery catheter assembly 12 is advanced over theguidewire so that the stent is positioned in the target area. Theexpandable member or balloon 22 is inflated by well known means so thatit expands radially outwardly and in turn expands the stent radiallyoutwardly until the stent is apposed to the vessel wall. The expandablemember is then deflated and the catheter withdrawn from the patient'svascular system.

The guidewire typically is left in the lumen for post-dilationprocedures, if any, and subsequently is withdrawn from the patientvascular system. As depicted in FIGS. 2 and 3, the balloon is fullyinflated with the prior art stent expanded and pressed against thevessel wall and, in FIG. 3, the implanted stent remains in the vesselafter the balloon has been deflated and the catheter assembly andguidewire have been withdrawn from the patient.

FIG. 4 illustrates the prior art stent 10 in some detail. The undulatingportion 27 of the links 28 are positioned between two struts 29A/29B.The links 28 all have the same undulating pattern on the strut.Consequently, the bending stiffness profile of the stent issubstantially constant along the length of the stent.

Typically, stent design has focused on maximizing the flexibility of thestent. However, less attention has been paid to the sharp change inflexibility of the stent delivery system at the beginning and endingpoints of the stent. FIG. 5 illustrates a stiffness profile of a typicaltraditional stent delivery system. As FIG. 5 illustrates, the stiffnessof the system sharply increases at the one end of the stent, with verylittle transition in stiffness between the stent and the portion of thestent delivery system immediately adjacent the stent. What is desired isa stent delivery system having a stent that smoothes the stiffnesstransition in the stent delivery system at the ends of the stent itself.

SUMMARY OF THE INVENTION

A flexible intravascular stent for use in a body lumen has a pluralityof rings interconnected to form a stent. The stent has a first endportion, a center portion, and a second end portion. At least one linkattaches each ring to an adjacent ring. To make the stent better matchthe stiffness profile of the stent delivery system, at least one of thefirst and second end portions has more bending flexibility than thecenter portion.

In one embodiment, the stent has a longitudinal axis, and the at leastone link attaching each ring to an adjacent ring has an undulating linkhaving a curved portion extending transverse to the stent's longitudinalaxis. To make the center stiffer than at least one of the two ends, thecurved portion of the links in the center section may have a curvaturethat is different (e.g. having different diameters) than the diameter ofthe curved portion of the links in at least one of the first end portionand the second end portion.

As an alternative, the links in at least one of the first end and thesecond end portions may be made of a stiffer, different material thanthe material of the links in the center portion. The links may be madeof, for example, polymer material, with the polymer at the first and/orsecond end of the stent being more stiff than the polymer at the centerportion. As another alternative, the links in at least one of the firstend and the second end portions may be thinner, in terms of thickness orwidth, than the links in the center portion.

As a further alternative, at least some of the links may comprise coils,the coils of links in at least one of the first and second end portionsbeing more flexible in bending than the coils in the center portion.Alternatively, at least some of the links may comprise nonlinearities,at least one of the first end portion and the second end portionincluding more nonlinearities per link than in the center portion. Forexample, the links may include undulating (e.g., bends, loops, arcs, sawtooth, square wave, sinusoidal, etc.) portions, the undulating portionson at least one of the first and second end portions being more flexiblein bending than the sinusoidal portions in the center portion.

In one embodiment, both the first and second end portions have morebending flexibility than the center portion. In another embodiment, thebending stiffness of the links gradually increases from at least one ofthe first and second end portions to the center portion.

These and other features and advantages of the invention will becomeapparent from the following detailed description, taken in conjunctionwith the accompanying drawings, which illustrate, by way of example, thefeatures of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view, partially in section, of a prior artstent mounted on a rapid exchange delivery catheter and positionedwithin an artery;

FIG. 2 is an elevational view, partially in section, similar to thatshown in FIG. 1 wherein the prior art stent is expanded within theartery so that the stent embeds within the arterial wall;

FIG. 3 is an elevational view, partially in section, showing theexpanded prior art stent implanted within the artery after withdrawal ofthe rapid exchange delivery catheter.

FIG. 4 is a plan view of a flattened prior art stent which illustratesthe pattern of the stent shown in FIGS. 1-3;

FIG. 5 is a plot showing, in very general terms, the stiffness profileof a prior art stent system, with the greatest stiffness being at thelocation of the stent;

FIGS. 6A-6C are views of another stent which illustrates a pattern ofrings and links;

FIG. 7 is a plan view of a stent according to the present invention inwhich the diameter of the “U”-shaped members increases toward the endsof the stent;

FIG. 8 is a generalized plot showing the relatively smooth transition instiffness at either end of the stent along the stent delivery system;

FIG. 9 is a plan view showing the pattern of another stent according tothe present invention, in which links are of different thicknesses;

FIG. 10 is a plan view showing the pattern of another stent according tothe present invention, in which links are made of different materials;

FIG. 11 is a plan view showing the pattern of another stent according tothe present invention, in which links have decreasing thickness towardthe ends of the stent; and

FIG. 12 is a plan view showing the pattern of another stent according tothe present invention, in which the links are coils, with the coilstoward the center of the stent being stiffer than coils toward the endsof the stent.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Considering now one existing stent design in some detail, FIGS. 6A-Cillustrate another type of stent, as described in U.S. Pat. No.6,629,994. FIGS. 6A-C depict stent 30 in various configurations.Referring to FIG. 6A, for example stent 30 is shown in a flattenedcondition so that the pattern can be clearly viewed, even though thestent is in a cylindrical form in use, such as shown in FIG. 6C. Thestent is typically formed from a tubular member, although, it can beformed from a flat sheet such as shown in FIG. 6A and rolled into acylindrical configuration as shown in FIG. 6C.

As shown in FIGS. 6A-6C, stent 30 is made up of a plurality ofcylindrical rings 40 which extend circumferentially around the stentwhen it is in a tubular form (see FIG. 6C). Each cylindrical ring 40 hasa cylindrical ring proximal end 46 and a cylindrical ring distal end 48.Typically, since the stent is laser cut from a tube there are nodiscreet parts such as the described cylindrical rings and links.However, it is beneficial for identification and reference to variousparts to refer to the cylindrical rings and links and other parts of thestent as follows.

Each cylindrical ring 40 defines a cylindrical plane 50 (FIG. 6C) whichis a plane defined by the proximal and distal ends 46,48 of the ring andthe circumferential extent as the cylindrical ring travels around thecylinder. Each cylindrical ring includes cylindrical outer wall surface52 which defines the outermost surface of the stent, and cylindricalinner wall surface 53 which defines the innermost surface of the stent.Cylindrical plane 50 follows the cylindrical outer wall surface.

Undulating link 54 is positioned within cylindrical plane 50. Theundulating links connect one cylindrical ring 40 to an adjacentcylindrical ring 40 and contribute to the overall longitudinalflexibility to the stent due to their unique construction. Theflexibility of the undulating links derives in part from curved portion56 connected to straight portions 58 wherein the straight portions aresubstantially perpendicular to the longitudinal axis of the stent. Thus,as the stent is being delivered through a tortuous vessel, such as acoronary artery, the curved portions 56 and straight portions 58 of theundulating links will permit the stent to flex in the longitudinaldirection. With the straight portions being substantially perpendicularto the stent longitudinal axis, the undulating link acts much like ahinge at the curved portion to provide flexibility.

As discussed previously with respect to FIG. 5, the design of FIGS.6A-6C results in a stent which has a substantially constant bendingstiffness across its length. It is desirable to design an alternativestent which has variable stiffness, with the least stiff portions beingat ends of the stent and the greatest stiffness being in the center ofthe stent. This variable stiffness profile reduces the change instiffness of the stent delivery system where the stent begins and ends.

Consistent with the present invention, FIG. 7 illustrates a stentpattern in which the undulating, generally “U-shaped” links 154 thatconnect the cylindrical rings 140 include straight portions 158 andcurved portions 156. Unlike the links of FIGS. 6A-6C, the straightportions of the links gradually increase in length toward either endfrom the center of the stent. In FIG. 7, the straight portions 158′ inthe undulating links 154′ at the ends of the stent are longer than thestraight portions 158 toward the center of the stent. Consequently, thestent has greater bending flexibility at the ends than at the center.The change in length from portions 158 near the center to portions 158′toward the ends may be gradual.

FIG. 8 illustrates a generalized stiffness plot of a stent deliverysystem incorporating a stent having the design of FIG. 7. FIG. 8illustrates that the transition in stiffness at either end of the stentis much more gradual than the similar transition illustrated in FIG. 5with respect to prior art stents.

There are a number of alternative ways in which variable flexibility canbe added to stents. In one embodiment that FIG. 9 illustrates, the linkslinking rings 240 have a curved portion. The radius of the curvedportions 256 is greater toward the ends of the stent (note the largerradii of curves 256′ and 256″ toward the ends of the stent as comparedto the smaller radius on the curve 256 toward the center of the stent.)The increase in radius from the curved link members at the center of thestent to the curved link members at the end of the stent may be gradual,to produce a gradually-changing stiffness profile. It should be notedthat the curve need not have a constant radius of curvature, but canvary, for example, with varying curvature as in a golf club sectionshape, or an oval section shape.

In another embodiment, the links are made of different materials.Referring to FIG. 10, the stent has rings 340 and links 354 a-d. Thelinks 354 a at the center portion may be made of a material that isrelatively stiff, whereas the links 354 b-d toward the end portions maybe made of a materials that are progressively less stiff. For example,the links at the center 354 a may be made of a relatively stiff polymer,whereas the links at the end portions may be made of relatively moreflexible polymers. The links may be attached to the rings by weldingmethods known in the art, for example.

In a further embodiment that FIG. 11 illustrates, links of differentthicknesses can be used. The stent includes rings 440 and links 454 a-d.The links 454 a in the center portion of the stent may be thicker thanthe links 454 b-d toward the end portions of the stent, which maygradually become thinner from the center of the stent outwardly towardthe ends, thereby creating a stent stiffness profile in which the stentis more flexible at the ends than at the center.

Another embodiment includes multiple non-linearities in the links. Thatis, the links in the center portion of the stent may have fewernon-linearities than links at the end portions of the stent. Forexample, referring to the prior art stent of FIGS. 1-3, a stentaccording to the present invention may modify the undulating links 27such that there are more curved members in links toward the ends than inlinks toward the center. That is, the number of non-linearities in thelinks increase toward the ends of the stent, thereby creating astiffness profile in which the ends of the stent are more flexible thanthe center of the stent.

In yet another embodiment, the links may be coils of material. Referringto FIG. 12, rings 540 are connected by coils. The coils 554 a at thecenter portion of the stent are stiffer than the coils 554 b at the endportions of the stent. It should be noted that the coils need not bepresent in every ring. Similarly, an undulation need not be in everyring.

In any of the foregoing embodiments, it is noted that the change instiffness may be gradual from the center to the end portions.Alternatively, the stiffness profile can be made relatively constantalong the length of the stent, but suddenly more flexible at the ends.As a further alternative, one end of the stent may be made more stiffthan the other end, if desired. These illustrative and non-limitingalternatives are provided merely to illustrate that many variations inthe stiffness profile of the stent are possible within the scope of theinvention.

The stent of the present invention can be mounted on a balloon cathetersimilar to that shown in the prior art device in FIG. 1. The stent istightly compressed or crimped onto the balloon portion of the catheterand remains tightly crimped onto the balloon during delivery through thepatient's vascular system. When the balloon is expanded, the stentexpands radially outwardly into contact with the body lumen, forexample, a coronary artery. When the balloon portion of the catheter isdeflated, the catheter system is withdrawn from the patient and thestent remains implanted in the artery. Similarly, if the stent of thepresent invention is made from a self-expanding metal alloy, such asnickel-titanium or the like, the stent may be compressed or crimped ontoa catheter and a sheath (not shown) is placed over the stent to hold itin place until the stent is ready to be implanted in the patient. Suchsheaths are well known in the art. Further, such a self-expanding stentmay be compressed or crimped to a delivery diameter and placed within acatheter. Once the stent has been positioned within the artery, it ispushed out of the catheter or the catheter is withdrawn proximally andthe stent held in place until it exits the catheter and self-expandsinto contact with the wall of the artery. Balloon catheters andcatheters for delivering self-expanding stents are well known in theart.

The stent of the present invention can be made in many ways. One methodof making the stent is to cut a thin-walled tubular member, such asstainless steel tubing to remove portions of the tubing in the desiredpattern for the stent, leaving relatively untouched the portions of themetallic tubing which are to form the stent. The stent also can be madefrom other metal alloys such as tantalum, nickel-titanium,cobalt-chromium, titanium, shape memory and superelastic alloys, and thenobel metals such as gold or platinum. In accordance with the invention,it is preferred to cut the tubing in the desired pattern by means of amachine-controlled laser as is well known in the art.

Other methods of forming the stent of the present invention can be used,such as using different types of lasers; chemical etching; electricdischarge machining; laser cutting a flat sheet and rolling it into acylinder; and the like, all of which are well known in the art at thistime.

The stent of the present invention also can be made from metal alloysother than stainless steel, such as shape memory alloys. Shape memoryalloys are well known and include, but are not limited to,nickel-titanium and nickel-titanium-vanadium. Any of the shape memoryalloys can be formed into a tube and laser cut in order to form thepattern of the stent of the present invention. As is well known, theshape memory alloys of the stent of the present invention can includethe type having superelastic or thermoelastic martensitictransformation, or display stress-induced martensit. These types ofalloys are well known in the art and need not be further described here.

Importantly, a stent formed of shape memory alloys, whether thethermoelastic or the stress-induced martensite-type, can be deliveredusing a balloon catheter of the type described herein, or be deliveredvia a catheter without a balloon or a sheath catheter.

The stent of the invention also can be coated with a drug or therapeuticagent to assist in repair of the lumen and may be useful, for example,in reducing the likelihood of the development of restenosis. Further, itis well known that the stent (usually made from a metal) may require aprimer material coating to provide a substrate on which a drug ortherapeutic agent is coated since some drugs and therapeutic agents donot readily adhere to a metallic surface. The drug or therapeutic agentcan be combined with a coating or other medium used for controlledrelease rates of the drug or therapeutic agent. Examples of therapeuticdrugs or pharmacologic compounds that may be loaded onto the stentpattern or into a polymeric coating on the stent, on a polymeric sleeve,or on individual filament strands on the stent, and delivered to thetarget site in the vasculature include taxol, aspirin, prostaglandins,and the like. Various therapeutic agents such as antithrombogenic orantiproliferative drugs are used to further control local thrombosis.Examples of therapeutic agents or drugs that are suitable for use inaccordance with the present invention include 17-beta estradiol,sirolimus, everolimus, actinomycin D (ActD), taxol, paclitaxel, orderivatives and analogs thereof. Examples of agents include otherantiproliferative substances as well as antineoplastic,antiinflammatory, antiplatelet, anticoagulant, antifibrin, antithrombin,antimitotic, antibiotic, and antioxidant substances. Examples ofantineoplastics include taxol (paclitaxel and docetaxel). Furtherexamples of therapeutic drugs or agents include antiplatelets,anticoagulants, antifibrins, antiinflammatories, antithrombins, andantiproliferatives. Examples of antiplatelets, anticoagulants,antifibrins, and antithrombins include, but are not limited to, sodiumheparin, low molecular weight heparin, hirudin, argatroban, forskolin,vapiprost, prostacyclin and prostacyclin analogs, dextran, D phe pro argchloromethylketone (synthetic antithrombin), dipyridamole, glycoproteinIIb/IIIa platelet membrane receptor antagonist, recombinant hirudin,thrombin inhibitor (available from Biogen located in Cambridge, Mass.),and 7E 3B® (an antiplatelet drug from Centocor located in Malvern, Pa.).Examples of antimitotic agents include methotrexate, azathioprine,vincristine, vinblastine, fluorouracil, adriamycin, and mutamycin.Examples of cytostatic or antiproliferative agents include angiopeptin(a somatostatin analog from Ibsen located in the United Kingdom),angiotensin converting enzyme inhibitors such as Captopril® (availablefrom Squibb located in New York, N.Y.), Cilazapril® (available fromHoffman LaRoche located in Basel, Switzerland), or Lisinopril®(available from Merck located in Whitehouse Station, N.J.); calciumchannel blockers (such as Nifedipine), colchicine, fibroblast growthfactor (FGF) antagonists, fish oil (omega 3 fatty acid), histamineantagonists, Lovastatin® (an inhibitor of HMG CoA reductase, acholesterol lowering drug from Merck), methotrexate, monoclonalantibodies (such as PDGF receptors), nitroprusside, phosphodiesteraseinhibitors, prostaglandin inhibitor (available from GlaxoSmithKlinelocated in United Kingdom), Seramin (a PDGF antagonist), serotoninblockers, steroids, thioprotease inhibitors, triazolopyrimidine (a PDGFantagonist), and nitric oxide. Other therapeutic drugs or agents whichmay be appropriate include alpha interferon, genetically engineeredepithelial cells, and dexamethasone.

While the foregoing therapeutic agents have been used to prevent ortreat restenosis, they are provided by way of example and are not meantto be limiting, since other therapeutic drugs may be developed which areequally applicable for use with the present invention. The treatment ofdiseases using the above therapeutic agents is known in the art. Thecalculation of dosages, dosage rates and appropriate duration oftreatment are previously known in the art. Furthermore, the therapeuticdrugs or agents are loaded at desired concentration levels per methodswell known in the art to render the device ready for implantation.

It should be understood that any reference in the specification orclaims to a drug or therapeutic agent being coated on the stent is meantthat one or more layers can be coated either directly on the stent oronto a primer material on the stent to which the drug or therapeuticagent readily attaches.

While the invention has been illustrated and described herein, in termsof its use as an intravascular stent, it will be apparent to thoseskilled in the art that the stent can be used in other body lumens.Further, particular sizes and dimensions, number of undulations orU-shaped portions or other nonlinearities per ring, materials used, andthe like have been described herein and are provided as examples only.Different combinations of the above mentioned features can be made, andnot every feature needs to be present in a particular embodiment. Notevery feature needs to be present in each ring, for instance, and evenin each ring, there can be combinations of features. For example, onesection may have links that are wider, shorter, thicker and withoutundulations, whereas another section can have links that are narrower,longer, thinner and having undulations. Other modifications andimprovements may be made without departing from the scope of theinvention.

I claim:
 1. A flexible stent for use in a body lumen, comprising: a plurality of rings interconnected to form a stent having a first end portion, a center portion, and a second end portion, the center portion having a ring length and a strut width; at least one link extending between each ring and an adjacent ring, wherein such link has a straight portion substantially parallel to a longitudinal axis of the stent and a curved portion extending transverse to the longitudinal axis, wherein such curved portion has a radius of curvature, and wherein the curved portion of the links in the center portion have a radius of curvature that is less than the radius of curvature of the curved portion of the links in at least one of the end portions such that said at least one end portion has more bending flexibility than the center portion.
 2. A flexible stent as defined in claim 1, wherein the radius of curvature of the curved portions of the links in the center portion is less than the radius of curvature in the links of both the first and second end portions.
 3. A flexible stent as defined in claim 1, wherein the radius of curvature of the curved portions of the links gradually decreases from at least one of the first and second end portions to the center portion.
 4. A flexible stent as defined in claim 1, wherein the stent is coated with at least one of a drug and a therapeutic agent.
 5. A flexible intravascular stent for use in a body lumen, comprising: a plurality of cylindrical rings aligned along a common longitudinal axis and interconnected to form a stent having a first end portion, a center portion, and a second end portion, each cylindrical ring having a first delivery diameter and a second implanted diameter; at least one link attaching each cylindrical ring to an adjacent cylindrical ring, the links being in the first end portion, the center portion, and the second end portion; each link having a curved portion extending transverse to the stent longitudinal axis and wherein the curved portion of the links in the center portion have a diameter less than the diameter of the curved portion of the links in at least one of the end portions.
 6. A flexible intravascular stent as defined in claim 5, wherein the curved portion of the links in the center portion have a diameter less than the diameter of the curved portion of the links of both the first and second end portions.
 7. A flexible intravascular stent for use in a body lumen, comprising: a plurality of cylindrical rings aligned along a common longitudinal axis and interconnected to form a stent having a first end portion, a center portion, and a second end portion, each cylindrical ring having a first delivery diameter and a second implanted diameter; at least one link attaching each cylindrical ring to an adjacent cylindrical ring, the links comprising a curved portion extending transverse to the longitudinal axis and wherein the curved portion of the links in the center portion have a smaller curvature than the curved portion of the links in at least one of the end portions.
 8. A flexible intravascular stent as defined in claim 7, wherein the links in the center portion have a curved portion with a smaller curvature than the curved portion of the links in both end portions.
 9. A flexible intravascular stent as defined in claim 7, wherein the curvatures of the curved portions of the links gradually decrease from at least one of the end portions to the center portion.
 10. A flexible intravascular stent as defined in claim 7, wherein the stent is coated with at least one of a drug and a therapeutic agent. 